510(k) · Cleared
ClearedReflex Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Aug 8, 2003 after a 67-day review. The FDA summary names its predicate without a number. 245 later devices descend from it.
- Decided
- Aug 8, 2003
- Review
- 67 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
245 later devices descend from it, 3 citing it directly.
- This deviceK031702 Reflex Anterior Cervical Plate SystemHowmedica Osteonics · 2003
- Descendant · cites it directly · 178 of its ownK040721 Assure Anterior Cervical Plate SystemGlobus Medical, Inc. · 2004
- Descendant · 2 generations on · 177 of its ownK070775 Modification to: Providence Anterior Cervical Plate SystemGlobus Medical, Inc. · 2007
- Descendant · 2 generations on · 171 of its ownK081391 Vip Anterior Cervical Plate SystemGlobus Medical, Inc. · 2008
- Descendant · 3 generations on · 155 of its ownK142218 Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc. · 2015
- Descendant · 4 generations on · 149 of its ownK152022 SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE®…Globus Medical, Inc. · 2017
Showing 5 of 245 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 245 · See all- K040721Assure Anterior Cervical Plate SystemGlobus Medical, Inc. · 2004 · cites it directly178descendants
- K070775Modification to: Providence Anterior Cervical Plate SystemGlobus Medical, Inc. · 2007 · 2 generations on177descendants
- K081391Vip Anterior Cervical Plate SystemGlobus Medical, Inc. · 2008 · 2 generations on171descendants
- K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc. · 2015 · 3 generations on155descendants
- K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc. · 2017 · 4 generations on149descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031702 | Reflex Anterior Cervical Plate System | Howmedica Osteonics | 2003 | — |
| +1 | K040721 | Assure Anterior Cervical Plate System | Globus Medical, Inc. | 2004 | — |
| +2 | K070775 | Modification to: Providence Anterior Cervical Plate System | Globus Medical, Inc. | 2007 | — |
| +2 | K081391 | Vip Anterior Cervical Plate System | Globus Medical, Inc. | 2008 | — |
| +3 | K142218 | Coalition AGX Plate and Coalition AGX Spacer | Globus Medical, Inc. | 2015 | — |
| +4 | K152022 | SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers… | Globus Medical, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 6 | 0 |
| 2017 | 7 | 0 |
| 2018 | 6 | 0 |
| 2019 | 11 | 0 |
| 2020 | 14 | 0 |
| 2021 | 16 | 0 |
| 2022 | 26 | 0 |
| 2023 | 28 | 0 |
| 2024 | 38 | 0 |
| 2025 | 37 | 0 |
| 2026 | 28 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KWQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KWQ device
- #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Synthes' Cervical Spine Locking Plate (CSLP) System Named without a submission number |
What descends from it? (245)
See all 2453 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K040721 (Globus Medical, Inc., 2004) has gone furthest, with 178 descendants of its own.
How does its category compare?
All KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
What is it indicated for?
The Reflex ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications: Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) Trauma (including…
Read the full statement (115 words)
The Reflex ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
Trauma (including fractures)
Tumors
Deformities or curvatures (including kyphosis, lordosis or scoliosis)
Pseudoarthrosis
Failed previous fusion
Decompression of the spinal cord following total or partial cervical vertebrectomy.
Spondylolisthesis
Spinal Stenosis
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031702 · printed Nov 4, 2026
Cite this page
510(k) Report. “K031702: Reflex Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K031702
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026